In the interim, the agency is advising doctors to get special training before using the product, to monitor patients closely for signs of infection and other complications, and to disclose possible complications to prospective patients in advance, the AP said.
FDA Cited for Lax Oversight of Foreign Drug Makers
The U.S. Food and Drug Administration has been lax in overseeing and inspecting foreign drug plants, the Government Accountability Office has found in a report to be released Wednesday.
According to the Wall Street Journal, the analysis by the investigative arm of the U.S. Congress comes as a House committee continues its investigation of the agency's handling of problems at two Indian plants run by generic drug maker Ranbaxy Laboratories. In September, the FDA banned import of 30 generic drugs produced at the two plants. The action came several years after the FDA first found manufacturing problems at one of the plants, the newspaper said.
In the five years ending in fiscal 2007, the FDA issued 15 warning letters to foreign drug makers that had serious problems, including manufacturing or record-keeping deficiencies. But only four of those companies were eventually re-inspected, the Journal reported.
In what the newspaper called "an unusual move," the GAO urged the FDA to conduct as many inspections of foreign drug makers as it performs on domestic ones.
The FDA has plans to open offices in China, India and Latin America, the newspaper said.